Ignite Creation Date:
2025-12-24 @ 4:16 PM
Ignite Modification Date:
2026-01-02 @ 7:47 AM
Study NCT ID:
NCT05165966
Status:
COMPLETED
Last Update Posted:
2022-08-11
First Post:
2021-12-20
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety and Immunogenicity Study of Booster Vaccination in Different Doses of COVID-19 Vaccine (Vero Cell),Inactivated for Prevention of COVID-19
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000086382', 'term': 'COVID-19'}], 'ancestors': [{'id': 'D011024', 'term': 'Pneumonia, Viral'}, {'id': 'D011014', 'term': 'Pneumonia'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D018352', 'term': 'Coronavirus Infections'}, {'id': 'D003333', 'term': 'Coronaviridae Infections'}, {'id': 'D030341', 'term': 'Nidovirales Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000722216', 'term': 'sinovac COVID-19 vaccine'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 340}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-10-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-12', 'completionDateStruct': {'date': '2022-07-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-08-09', 'studyFirstSubmitDate': '2021-12-20', 'studyFirstSubmitQcDate': '2021-12-20', 'lastUpdatePostDateStruct': {'date': '2022-08-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-12-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-04-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Immunogenicity index-GMI of neutralizing antibodies(CZ02 strain)', 'timeFrame': '14 days after the booster dose vaccination', 'description': 'GMI of neutralizing antibodies(CZ02 strain) 14 days after the booster dose vaccination'}, {'measure': 'Immunogenicity index-seroconversion rate of neutralizing antibodies(CZ02 strain)', 'timeFrame': '14 days after the booster dose vaccination', 'description': 'The seroconversion rate of neutralizing antibodies(CZ02 strain) 14 days after the booster dose vaccination'}, {'measure': 'Immunogenicity index-GMT of neutralizing antibodies(CZ02 strain)', 'timeFrame': '7 days after the booster dose vaccination', 'description': 'GMT of neutralizing antibodies(CZ02 strain) 7 days after the booster dose vaccination'}, {'measure': 'Immunogenicity index-Seropositivity rate of neutralizing antibodies(CZ02 strain)', 'timeFrame': '7 days after the booster dose vaccination', 'description': 'Seropositivity rate of neutralizing antibodies(CZ02 strain) 7 days after the booster dose vaccination'}, {'measure': 'Immunogenicity index-GMI of neutralizing antibodies(CZ02 strain)', 'timeFrame': '7 days after the booster dose vaccination', 'description': 'GMI of neutralizing antibodies(CZ02 strain)7 days after the booster dose vaccination'}, {'measure': 'Immunogenicity index-seroconversion rate of neutralizing antibodies(CZ02 strain)', 'timeFrame': '7 days after the booster dose vaccination', 'description': 'The seroconversion rate of neutralizing antibodies(CZ02 strain) 7 days after the booster dose vaccination'}, {'measure': 'Immunogenicity index-GMT of neutralizing antibodies(CZ02 strain)', 'timeFrame': '28 days after the booster dose vaccination', 'description': 'GMT of neutralizing antibodies(CZ02 strain) 28 days after the booster dose vaccination'}, {'measure': 'Immunogenicity index-Seropositivity rate of neutralizing antibodies(CZ02 strain)', 'timeFrame': '28 days after the booster dose vaccination', 'description': 'Seropositivity rate of neutralizing antibodies(CZ02 strain) 28 days after the booster dose vaccination'}, {'measure': 'Immunogenicity index-GMI of neutralizing antibodies(CZ02 strain)', 'timeFrame': '28 days after the booster dose vaccination', 'description': 'GMI of neutralizing antibodies(CZ02 strain)28 days after the booster dose vaccination'}, {'measure': 'Immunogenicity index-seroconversion rate of neutralizing antibodies(CZ02 strain)', 'timeFrame': '28 days after the booster dose vaccination', 'description': 'The seroconversion rate of neutralizing antibodies(CZ02 strain) 28 days after the booster dose vaccination'}, {'measure': 'Immunogenicity index-GMT of neutralizing antibodies(CZ02 strain)', 'timeFrame': '3 months after the booster dose vaccination', 'description': 'GMT of neutralizing antibodies(CZ02 strain) 3 months after the booster dose vaccination'}, {'measure': 'Immunogenicity index-seroconversion rate of neutralizing antibodies(CZ02 strain)', 'timeFrame': '3 months after the booster dose vaccination', 'description': 'The seroconversion rate of neutralizing antibodies(CZ02 strain)3 months after the booster dose vaccination'}, {'measure': 'Immunogenicity index-GMT of neutralizing antibodies(CZ02 strain)', 'timeFrame': '6 months after the booster dose vaccination', 'description': 'GMT of neutralizing antibodies(CZ02 strain) 6 months after the booster dose vaccination'}, {'measure': 'Immunogenicity index-GMT of neutralizing antibodies(Delta strain)', 'timeFrame': '14 days after the booster dose vaccination', 'description': 'GMT of neutralizing antibodies(Delta strain) 14 days after the booster dose vaccination'}, {'measure': 'Immunogenicity index-Seropositivity rate of neutralizing antibodies(Delta strain)', 'timeFrame': '14 days after the booster dose vaccination', 'description': 'Seropositivity rate of neutralizing antibodies (Delta strain) 14 days after the booster dose vaccination'}, {'measure': 'Immunogenicity index-GMI of neutralizing antibodies(Delta strain)', 'timeFrame': '14 days after the booster dose vaccination', 'description': 'GMI of neutralizing antibodies(Delta strain) 14 days after the booster dose vaccination'}, {'measure': 'Immunogenicity index-seroconversion rate of neutralizing antibodies(Delta strain)', 'timeFrame': '14 days after the booster dose vaccination', 'description': 'The seroconversion rate of neutralizing antibodies (Delta strain) 14 days after the booster dose vaccination'}, {'measure': 'Immunogenicity index-GMT of neutralizing antibodies(Omicron Strain)', 'timeFrame': '14 days after the booster dose vaccination', 'description': 'GMT of neutralizing antibodies(Omicron Strain) 14 days after the booster dose vaccination'}, {'measure': 'Immunogenicity index-Seropositivity rate of neutralizing antibodies(Omicron Strain)', 'timeFrame': '14 days after the booster dose vaccination', 'description': 'Seropositivity rate of neutralizing antibodies (Omicron Strain) 14 days after the booster dose vaccination'}, {'measure': 'Immunogenicity index-GMI of neutralizing antibodies(Omicron Strain)', 'timeFrame': '14 days after the booster dose vaccination', 'description': 'GMI of neutralizing antibodies(Omicron Strain) 14 days after the booster dose vaccination'}, {'measure': 'Immunogenicity index-seroconversion rate of neutralizing antibodies(Omicron Strain)', 'timeFrame': '14 days after the booster dose vaccination', 'description': 'The seroconversion rate of neutralizing antibodies (Omicron Strain) 14 days after the booster dose vaccination'}], 'primaryOutcomes': [{'measure': 'Immunogenicity index-GMT of neutralizing antibodies(CZ02 strain)', 'timeFrame': '14 days after the booster dose vaccination', 'description': 'GMT of neutralizing antibodies(CZ02 strain) 14 days after the booster dose vaccination'}], 'secondaryOutcomes': [{'measure': 'Immunogenicity index-Seropositivity rate of neutralizing antibodies(CZ02 strain)', 'timeFrame': '14 days after the booster dose vaccination', 'description': 'Seropositivity rate of neutralizing antibodies(CZ02 strain) 14 days after the booster dose vaccination'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['COVID-19']}, 'descriptionModule': {'briefSummary': 'This is a randomized, double-blinded, phase Ⅳ clinical trial of COVID-19 vaccine (Vero cell), Inactivated manufactured by Sinovac Life Sciences Co. , Ltd. The purpose of this study is to evaluate the safety and immunogenicity of booster vaccination using high-dosage or medium-dosage of COVID-19 vaccine (Vero cell), Inactivated in populations who have completed primary immunization 5-9 months', 'detailedDescription': 'This study a randomized, double-blinded, phase Ⅳ clinical trial of COVID-19 vaccine (Vero cell), Inactivated.The purpose of this study is to evaluate the safety and immunogenicity of booster vaccination using high-dosage or medium-dosage of COVID-19 vaccine (Vero cell), Inactivated in populations who have completed primary immunization 5-9 months.A total of 340 subjects who have completed primary immunization using two-dose Coronavac® 5-9 months were be enrolled.All of subjects were be randomly divided into two groups in a 1:1 ratio to receive high-dosage or medium-dosage of COVID-19 vaccine (Vero cell), Inactivated.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Healthy participants aged 18 years and above;\n* Proven legal identity;\n* The subjects can understand and voluntarily sign the informed consent form and be willing to complete the study in accordance with the study plan;\n* Have received two doses of inactivated COVID-19 vaccine (CoronaVac®) manufactured by Sinovac Research \\& Development Co., Ltd and that is currently 5-9 months after the second dose.\n\nExclusion Criteria:\n\n* History of SARS-CoV-2 infection(laboratory confirmed);\n* Have received three and more doses of inactivated COVID-19 vaccine;\n* Known allergy to vaccines or vaccine ingredients, and serious adverse reactions to vaccines, such as urticaria, dyspnea, angioneurotic edema;\n* Autoimmune disease such as systemic lupus erythematosus or immunodeficiency / immunosuppression such as AIDS, post-transplant;\n* Severe chronic diseases, severe cardiovascular diseases, hypertension and diabetes that cannot be controlled by drugs, liver or kidney diseases, malignant tumors, etc;\n* Severe neurological disease (epilepsy, convulsions or convulsions) or mental illness;\n* Diagnosed abnormal blood coagulation function (eg, lack of blood coagulation factors, blood coagulopathy, abnormal platelets) or obvious bruising or blood coagulation;\n* Immunosuppressive therapy, cytotoxic therapy, inhaled corticosteroids(excluding allergic rhinitis corticosteroid spray therapy, acute noncomplicated dermatitis superficial corticosteroid therapy) in the past 6 months;\n* History of alcohol or drug abuse;\n* Receipt of blood products within in the past 3 months;\n* Receipt of other investigational drugs in the past 30 days;\n* Receipt of attenuated live vaccines in the past 14 days;\n* Acute diseases or acute exacerbation of chronic diseases within 7 days prior to booster vaccination;\n* Axillary temperature \\>37.0°C;\n* Participated in other clinical trials prior to enrollment and during the followup period, or planned to participate in other clinical trials during the clinical trial period;\n* According to the investigator's judgment, the subject has any other factors that are not suitable for participating in the clinical trial."}, 'identificationModule': {'nctId': 'NCT05165966', 'briefTitle': 'Safety and Immunogenicity Study of Booster Vaccination in Different Doses of COVID-19 Vaccine (Vero Cell),Inactivated for Prevention of COVID-19', 'organization': {'class': 'INDUSTRY', 'fullName': 'Sinovac Biotech Co., Ltd'}, 'officialTitle': 'A Randomized, Double-Blinded Clinical Trial to Evaluate the Immunogenicity Using Additional Dose of Medium-dosage or High-dosage COVID-19 Vaccine (Vero Cell), Inactivated in Populations Who Have Completed Primary Immunization 5-9 Months', 'orgStudyIdInfo': {'id': 'PRO-nCOV-4010'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Experimental Group-High-dosage of COVID-19 vaccine (Vero cell), Inactivated', 'description': '170 participants will receive one dose of booster vaccination with high-dosage of COVID-19 vaccine (Vero cell), Inactivated.', 'interventionNames': ['Biological: High-dosage of COVID-19 vaccine (Vero cell), Inactivated']}, {'type': 'EXPERIMENTAL', 'label': 'Experimental Group-Medium-dosage of COVID-19 vaccine (Vero cell), Inactivated', 'description': '170 participants will receive one dose of booster vaccination with medium-dosage of COVID-19 vaccine (Vero cell), Inactivated.', 'interventionNames': ['Biological: Medium-dose COVID-19 Vaccine(Vero Cell),Inactivated']}], 'interventions': [{'name': 'High-dosage of COVID-19 vaccine (Vero cell), Inactivated', 'type': 'BIOLOGICAL', 'otherNames': ['High-dose CoronaVac®'], 'description': 'High-dose COVID-19 Vaccine(Vero Cell),Inactivated:1200SU inactivated SARS-CoV-2 virus in 0.5 mL of aluminium hydroxide solution per injection', 'armGroupLabels': ['Experimental Group-High-dosage of COVID-19 vaccine (Vero cell), Inactivated']}, {'name': 'Medium-dose COVID-19 Vaccine(Vero Cell),Inactivated', 'type': 'BIOLOGICAL', 'otherNames': ['Medium-dose CoronaVac®'], 'description': 'Medium-dose COVID-19 Vaccine(Vero Cell),Inactivated: 600SU inactivated SARS-CoV-2 virus in 0.5 mL of aluminium hydroxide solution per injection', 'armGroupLabels': ['Experimental Group-Medium-dosage of COVID-19 vaccine (Vero cell), Inactivated']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100069', 'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'facility': 'Beijing Youan Hospital Capital Medical University', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'overallOfficials': [{'name': 'Yingmei Feng, Master', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Beijing YouAn Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sinovac Life Sciences Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}